Piccolo Chloride Test System
by Abaxis, Inc.
510(k) K010670
Piccolo Chloride Test System is a Class II device made by Abaxis, Inc., cleared under FDA 510(k) K010670 on 26 Apr 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010670 | Date26 Apr 2001 | StatusActive |
Official records
- FDA 510(k) database K010670
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CHJ
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1170
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K010670
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Piccolo Basic Metabolic Panel 400-0024 | 400-0024 / 400-0024 | EABA40000241 | — | On the market |
| Piccolo Basic Metabolic Panel Plus 400-0031 | 400-0031 / 400-0031 | EABA40000311 | — | On the market |
| Piccolo Comprehensive Metabolic Panel 400-0028 | 400-0028 / 400-0028 | EABA40000281 | — | On the market |
| Piccolo Electrolyte Panel 400-0022 | 400-0022 / 400-0022 | EABA40000221 | — | On the market |
| Piccolo MetLac 12 Panel 400-0037 | 400-0037 / 400-0037 | EABA40000371 | — | On the market |
| Piccolo MetLyte 8 Panel 400-0023 | 400-0023 / 400-0023 | EABA40000231 | — | On the market |
| Piccolo MetLyte Plus CRP 400-0034 | 400-0034 / 400-0034 | EABA40000341 | — | On the market |
| Piccolo Renal Function Panel 400-0027 | 400-0027 / 400-0027 | EABA40000271 | — | On the market |
Similar devices
Other devices filed under FDA product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride).
- PARAMAX CHLORIDE REAGENT by American Dade
- URINE CHLORIDE by Heraeus Kulzer, Inc.
- TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE by Technicon Instruments Corp.
- OLYMPUS CHLORIDE REAGENT by Olympus Corp.
- BIOTROL CHLORIDE by Biotrol, USA, Inc.
- CHLORIDE REAGENT SET by Tech-Neal Scientific, Inc.
- KING DIAGNOSTICS CHLORIDE REAGENT by King Diagnostics, Inc.
- CHLORIDE REAGENT by POINTE SCIENTIFIC, INC.
- CHLORIDE TEST KIT by Mallinckrodt Critical Care
- ROCHE REAGENT FOR CHLORIDE by Roche Diagnostic Systems, Inc.